India says it needs less stability data for API exports

India cuts stability data reqs for API firms seeking docs to ship to EU

30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.

Animals will test the device on the International Space Station. (Picture: NASA)

Life on Mars? Ground control to remotely deliver drugs in space

30-Oct-2014 - Animal astronauts on the International Space Station will test an implant which allows doctors back on earth to deliver drugs by remote control.

Pharma: can make tablets; can't make apps people download to tablets

Apps pathetic: Drug industry mobile techs underperforming

30-Oct-2014 - Hardly anybody downloads Big Pharma apps according to a new report that suggests drugmakers seeking greater mHealth engagement should ditch the product-focused model and seek expert help.

Novo has turned around the biomanufacturing facility quickly

Novo Nordisk to hire 90 at newly acquired plant in New Hampshire

30-Oct-2014 - Novo Nordisk on Wednesday announced plans to hire up to 90 people at its newly-acquired manufacturing facility in West Lebanon, New Hampshire. 

India plans to ban PET for liquid drugs next month

Auf Wiedersehen PET? India to ban plastic bottles for liquid drugs

29-Oct-2014 - India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.

“The Board of Directors thanks Christopher A. Viehbacher for all the work done during the last six years, which has enabled the Group to move through a sensitive and important transition phase."

Sanofi's US-based CEO Viehbacher resigns after board votes to remove him

29-Oct-2014 - So it appears the future of Sanofi’s CEO Christopher Viehbacher was on the agenda after all.

RSA's Nick Stephens told why Pfizer fared poorly in the poll. (Picture: Ben Frost/Flickr)

Why there's no sign of Pfizer among top pharma employers

29-Oct-2014 - A head-hunter explains why Regeneron, Novo Nordisk and Genentech top a global survey of science employers, but Pfizer is nowhere to be seen in the top 20.

EDQM sets new policy for testing of bacterial endotoxins

EDQM sets new policy for testing of bacterial endotoxins

29-Oct-2014 - The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.

Pharma Action's new crude heparin plant will source only from European slaughterhouses operated by parent Toennies

Pharma Action crude heparin plant due to open next week

28-Oct-2014 - A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.

Fluoxetine 20mg: under new rules, Prozac would no longer be called an 'antidepressant'. (Picture: Tom Varco/Flickr)

Neuro experts call for drug name shake-up; manufacturers more cautious

28-Oct-2014 - Psychiatric drugs should be renamed according to their chemical make-up, not the symptoms they treat, according to leading neuropsychopharmacologists.

(Picture credit: Flickr/Ben Pennells)

Hikma confirms FDA sent Warning Letter for environmental issues

28-Oct-2014 - Jordanian drugmaker Hikma says it has received a US FDA (Food and Drug Administration) Warning Letter over environmental monitoring at its plant in Portugal.

People on the Move

People on the Move

27-Oct-2014 - Former employees of Procter & Gamble, Merck & Co. and Bristol Myers Squibb have all found new homes in the pharma industry in this week's People column.

Tower of Basel: Roche spends $3bn on giant R&D site

Tower of Basel: Roche spends $3bn on giant R&D site

27-Oct-2014 - Roche has announced plans to invest 3bn Swiss Francs ($3.2bn) in a 433-ft R&D centre and extra offices for 3,600 employees.

EMA says polymyxins can be given via nebuliser to treat Pseudomonas aeruginosa in cystic fibrosis patients

Superbug-driven surge in polymyxin demand prompts EMA to reassess safety info

27-Oct-2014 - A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives

Production facilities at Novo Nordisk's Kalundborg plant

Novo Nordisk subpoenaed over Danish manufacturing site

27-Oct-2014 - Novo Nordisk has been served with a subpoena over alleged manufacturing issues at its site in Kalundborg, Denmark.

Lawyers question legality of FDA final guidance on inspections

Lawyers question legality of US FDA final guidance on delaying, denying inspections

27-Oct-2014 - What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance, “critically vague and legally questionable in several ways.”

When does API production start? EMA says clarification needed

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.

GSK is looking to save £1bn a year over the next three years

GSK £1bn savings plan to hit manufacture towards 2017, but UK likely immune

23-Oct-2014 - GlaxoSmithKline plans to cut manufacturing, sales and R&D as part of a three year plan to save £1bn ($1.6bn) annually. 

EMA launches rolling Ebola vaccine review plan

EMA launches rolling review process for Ebola vaccine makers

23-Oct-2014 - Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.    

Actavis continues to chop down Forest network post $28bn acquisition

Actavis takes axe to Forest again, with New York jobs to go

23-Oct-2014 - Almost 100 jobs at a commercial packaging facility in New York are set to go as part of Actavis’s continued integration of Forest Laboratories.